Publications

The SEESAW study: Efficacy and safety of levodopa/ DDCI and entacapone in Parkinson's disease patients with motor fluctuations. In this randomized, double-blind, placebo-controlled, multicentre, North-American trial, 205 idiopathic PD patients experiencing motor fluctuations received either levodopa/DDCI and entacapone or levodopa/DDCI and placebo. During this 24-week trial, patients on levodopa/DDCI and entacapone therapy benefited from an increase in ON-time compared with those receiving levodopa/DDCI and placebo. In those patients with a smaller percentage ON-time at baseline benefits were more prominent and increased throughout the day, suggesting that levodopa/DDCI and entacapone is effective in increasing the levodopa-response duration. Levodopa/DDCI and entacapone treatment was well tolerated during the 24-week treatment period.

The NOMECOMT study: Efficacy and safety of levodopa/DDCI and entacapone therapy in PD patients with wearing-off motor fluctuations. In this Nordic study (Denmark, Finland, Norway and Sweden), 171 parkinsonian patients with wearing-off-type motor fluctuations participated in a 6-month randomized, placebo-controlled, double-blind, parallel-group study, in which patients received levodopa/DDCI and entacapone or levodopa/DDCI and placebo. An increase in daily ON-time with corresponding decrease in OFF-time was observed with levodopa/DDCI and entacapone treatment compared with levodopa/DDCI and placebo as measured by changes in UPDRS score. These symptom improvements occurred irrespective of the reduction in mean daily levodopa intake. Treatment with levodopa/DDCI and entacapone effectively prolonged the beneficial response to levodopa in parkinsonian patients with wearing-off type motor fluctuations.

The CELOMEN study: Efficacy and safety of levodopa/DDCI and entacapone therapy in PD patients with motor fluctuations. A randomized, double-blind, placebo-controlled, multicentre study in Germany and Austria; 301 patients were randomized to either levodopa/DDCI and entacapone or levodopa/DDCI and placebo. At 24 weeks, in those patients treated with levodopa/DDCI and entacapone a significant improvement in both activities of daily living and in UPDRS motor scores were observed in the total population, compared with those in the placebo group. The amount of time spent in ON- and OFF-time improved in patients receiving levodopa/DDCI and entacapone. Levodopa/DDCI and entacapone therapy was an effective and well tolerated treatment.

The UK-IRISH study: Efficacy and safety of entacapone in levodopa/DDCI and entacapone- treated PD patients with and without motor fluctuation. A randomized, double-blind, placebo-controlled, multicentre in the UK and Ireland, in which 128 stable and 172 unstable patients were randomized to receive either levodopa/DDCI and entacapone or levodopa/DDCI and placebo. At 6 months, patients in the levodopa/DDCI and entacapone-treated group had a significant increase in the proportion of daily ON-time compared with those in the levodopa/DDCI and placebo-treated group. The benefits afforded by levodopa/DDCI and entacapone therapy also extend to patients who are not experiencing motor fluctuations, as seen by an improvement in activity of daily living scores.

The NOMESAFE study; the long-term safety and efficacy 3-year, open-label extension of the 6-months, double-blind, placebo-controlled Nordic (NOMECOMT) study. After the initial washout period, 132 patients experiencing symptom re-emergence due to wearing-off were treated with levodopa/DDCI and entacapone. The findings in this study showed a significant increase in the benefit of a single dose of levodopa at 3 months, and these benefits remained for the duration of the 3-year study period. Mean daily dose of levodopa was significantly decreased from baseline to endpoint. NOMESAFE demonstrated the long-term safety profile of levodopa/DDCI and entacapone therapy in addition to a sustained beneficial effect in patients with PD experiencing symptom re-emergence due to wearing-off.